Blitzima

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

rituximab

Διαθέσιμο από:

Celltrion Healthcare Hungary Kft.

Φαρμακολογική κατηγορία (ATC):

L01FA01

INN (Διεθνής Όνομα):

rituximab

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Θεραπευτικές ενδείξεις:

Blitzima is indicated in adults for the following indications:Non-Hodgkin’s lymphoma (NHL)Blitzima is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.Blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.Blitzima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.Blitzima is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.Chronic lymphocytic leukaemia (CLL)Blitzima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Blitzima or patients refractory to previous Blitzima plus chemotherapy.

Περίληψη προϊόντος:

Revision: 19

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-07-13

Φύλλο οδηγιών χρήσης

70
B. PACKAGE LEAFLET
71
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BLITZIMA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION
BLITZIMA 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION
rituximab
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Blitzima is and what it is used for
2.
What you need to know before you use Blitzima
3.
How to use Blitzima
4.
Possible side effects
5.
How to store Blitzima
6.
Contents of the pack and other information
1.
WHAT BLITZIMA IS AND WHAT IT IS USED FOR
WHAT BLITZIMA IS
Blitzima contains the active substance “rituximab”. This is a type
of protein called a “monoclonal
antibody”. It sticks to the surface of a type of white blood cell
called “B-Lymphocyte”. When
rituximab sticks to the surface of this cell, the cell dies.
WHAT BLITZIMA IS USED FOR
Blitzima may be used for the treatment of several different conditions
in adults and children. Your
doctor may prescribe Blitzima for the treatment of:
A)
NON-HODGKIN’S LYMPHOMA
This is a disease of the lymph tissue (part of the immune system) that
affects a type of white blood cell
called B-Lymphocytes.
In adults, Blitzima can be given alone or with other medicines called
“chemotherapy”.
In adult patients where the treatment is working, Blitzima may be
continued for 2 years after
completing the initial treatment.
In children and adolescents, Blitzima is given in combination with
“chemotherapy”.
B)
CHRONIC LYMPHOCYTIC LEUKAEMIA
Chronic lymphocytic leukaemia (CLL) is the most common form of adult
leukaemia. CLL affects a
particular lymphocyte, the B cell, which originates from the bone
marrow and develops in the lymph
nodes. Patients with CLL ha

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Blitzima 100
mg concentrate for solution for infusion
Blitzima 500 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Blitzima 100
mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 10 mL vial contains 100 mg of rituximab.
Blitzima 500
mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 50 mL vial contains 500 mg of rituximab.
Rituximab is a genetically engineered chimeric mouse/human monoclonal
antibody representing a
glycosylated immunoglobulin with human IgG1 constant regions and
murine light
-
chain and
heavy
-
chain variable region sequences. The antibody is produced by mammalian
(Chinese hamster
ovary) cell suspension culture and purified by affinity chromatography
and ion exchange, including
specific viral inactivation and removal procedures.
Excipients with known effect
Each 10 mL vial contains 2.3 mmol (52. 6 mg) sodium.
Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless liquid with pH of 6.3 – 6.8 and osmolality of 329
– 387 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Blitzima is indicated in adults for the following indications:
Non-Hodgkin’s lymphoma (NHL)
Blitzima is indicated for the treatment of previously untreated adult
patients with stage III-IV
follicular lymphoma in combination with chemotherapy.
Blitzima maintenance therapy is indicated for the treatment of adult
follicular lymphoma
patients responding to induction therapy.
Blitzima monotherapy is indicated for treatment of adult patients with
stage III-IV follicular
lymphoma who are chemo-resistant or are in their second or subsequent
relapse after chemotherapy.
Blitzima is indicated for the treatment of adult patients with CD20
positive diffuse large B cell
non-Hodgkin’s lymphoma in combination with CHOP (cycl